On September 11, the FDA authorized updated COVID-19 vaccines from Pfizer-BioNTech and Moderna, targeting the Omicron variant. Novavax’s vaccine is pending FDA review. Pfizer and Moderna’s shots, approved for ages 12 and above, are set to roll out soon. CDC endorsement is expected, following a late-summer COVID surge, driven by the EG.5 subvariant. Novavax aims for imminent U.S. approval. The government continues to offer free vaccines for insured Americans and is working on a program for the uninsured.
On September 11, the U.S. Food and Drug Administration (FDA) granted authorization for updated COVID-19 vaccines developed by Pfizer-BioNTech and Moderna. These vaccines specifically target the recently prevalent Omicron variant of the coronavirus, known as XBB.1.5 subvariant. This clearance paves the way for the launch of a fall vaccination campaign, set to commence later this week.
Meanwhile, a third vaccine produced by Novavax is still under FDA review. Novavax expects this vaccine to gain authorization in the United States after a meeting of a Centers for Disease Control and Prevention (CDC) advisory panel on Tuesday, where recommendations for its usage will be made. Following this news, Novavax’s shares closed down approximately 13% at $7.82.
Both Pfizer and Moderna have indicated that their updated vaccines will become available to most individuals in the United States in the coming days. The FDA has approved these shots for individuals aged 12 and older and has also authorized emergency use for children between 6 months and 11 years of age.
Dr. Peter Marks, a prominent FDA scientist, emphasized that these updated vaccines meet the agency’s stringent criteria for safety, efficacy, and manufacturing quality. He encouraged eligible individuals to consider getting vaccinated.
CDC Director Mandy Cohen is expected to endorse these new vaccines in the coming days, further facilitating their rollout, which is anticipated to begin in September.
The FDA’s decision to authorize these vaccines follows a surge in COVID-19 cases during late summer, coinciding with the emergence of the EG.5 subvariant of Omicron, known as “Eris,” which has been rapidly spreading in the United States and other countries. Concerns have also arisen regarding the highly mutated BA.2.86 subvariant detected in multiple countries.
Pfizer and Moderna reported strong responses from their updated COVID-19 vaccines against the BA.2.86 subvariant in recent testing. Novavax is still assessing the effectiveness of its vaccine against this subvariant, as stated by the company’s Chief Executive, John Jacobs.
Novavax is optimistic about receiving U.S. authorization for its vaccine soon, as they work in collaboration with regulatory authorities. The company has produced substantial quantities of its new vaccine and has secured distribution contracts nationwide.
It is worth noting that Novavax’s protein-based vaccine employs older technology compared to the messenger RNA (mRNA) vaccines, which have been in use for decades to combat various diseases.
Jesse Goodman, a professor at Georgetown University and former FDA chief scientist, emphasized the importance of FDA data supporting full approval for Novavax’s vaccine.
The U.S. government had previously declared an end to the COVID public health emergency in May and transitioned vaccination responsibility to the private sector. Although demand for the vaccine has significantly declined, COVID vaccines will continue to be provided free of charge to most Americans with health insurance coverage. Additionally, the government is working on a program to offer free vaccines to individuals without insurance.